VTI INTERFUSE T SURGICAL TECHNIQUE FORWARD THINKING FOR THE BACK. 1/20

Transcription

1 VTI INTERFUSE T SURGICAL TECHNIQUE FORWARD THINKING FOR THE BACK. 1/20

2 CONTENTS InterFuse T Product Description Indications for Use X-Ray Marker Locations Product Specifications Instrument Set STEP ONE: PREOPERATIVE PLANNING Patient Positioning 7 STEP TWO: DISC REMOVAL AND ENDPLATE SHAPING Identify Landmarks Distraction Access Channel Annulotomy and Cortical Rim Nucleus Removal STEP THREE: DEVICE SIZING AND PREPARATION Sizing Bone Graft Material 11 STEP FOUR: IMPLANTATION A Module Insertion B Module Insertion Tail Removal C Module Insertion Module Disengagement Closure Postoperative Care Product Listing Additional Information VTI VTI-SPINE.COM 2/20

3 INTERFUSE T PRODUCT DESCRIPTION The VTI InterFuse T implant is an interbody fusion device that combines the large vertebral endplate contact area characteristic of many ALIF devices with the ability to implant through a less invasive transforaminal lumbar interbody fusion (TLIF) approach. The unique design of the InterFuse T device incorporates an anatomical shape that assures contact with the peripheral margins and the well-vascularized central portion of the vertebral endplate, areas shown to be critical to proper loading and for reduction of subsidence risk. The interlocking design provides the necessary structural support and endplate contact area while the open caudal and cephalad spaces accommodate new bone growth and fusion. The InterFuse T is made of radiolucent PEEK-OPTIMA to provide structural strength with nearly the same stiffness of cortical bone while maintaining the ability to assess fusion progress radiographically. The InterFuse T device incorporates tantalum markers to aid in visualizing the device during intraoperative and postoperative radiographic assessment. The unique rail-andslot design assures proper placement and alignment of each segment. The rail extensions are made of stainless steel. The VTI InterFuse T device is available in seven heights (7mm, 8mm, 9mm, 10mm, 11mm, 12mm, and 14mm) in parallel and 10º lordotic configurations. The devices have a 20 mm AP length. The device is supplied sterile. INDICATIONS FOR USE The InterFuse T Intervertebral Body Fusion Device is indicated for intervertebral spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The InterFuse T device is to be used in patients who have had at least six (6) months of non-operative treatment. These patients may have had a previous non-fusion surgery at the involved spinal level(s). The InterFuse T device is indicated for use with autogenous bone graft, and to be used with supplemental internal spinal fixation systems that have been cleared for use by the FDA in the lumbosacral spine. VTI VTI-SPINE.COM 3/20

4 X-RAY MARKER LOCATION AND PRODUCT SPECIFICATIONS 26 mm 9 mm 16 mm 9 mm 25.5 mm 8 mm 20 mm HEIGHT 28.7 mm A B C 2.5 mm VTI VTI-SPINE.COM 4/20

5 INSTRUMENT SET* THREADED INSERTER INSERTION GUARD NUCLEUS PROBE TAIL TRACTION TOOL *Instruments are not to scale VTI VTI-SPINE.COM 5/20

6 POSITIONING LEVER TAIL REMOVAL TOOL DEVICE SIZER SLAP HAMMER EXTRACTOR TOOL MODULE DISENGAGEMENT *Instruments are not to scale VTI VTI-SPINE.COM 6/20

7 STEP ONE PREOPERATIVE PLANNING Preoperative planning is recommended for determining the height of the InterFuse T device that will most likely provide the best fit and fill in the patient s disc space. Determine the approximate implant height required for the patient by using sagittal measurements of the intervertebral discs adjacent to the disc being treated on MRI obtained within the previous six (6) months. An alternate method is to use digitally-aided lateral radiographs. Select the device height that most closely matches, but does not exceed, the disc height of the adjacent levels. The implant must fit securely between the endplates when the segment is fully distracted. It is essential to use the tallest possible implant, as determined by the preoperative planning, to maximize segmental stability. Due to variations in radiographic magnification, these measurements provide only an estimate of the ideal implant size. Final device sizing must be performed just prior to implant insertion using the sizing instruments provided. Actual lateral dimension of the InterFuse T device is determined intraoperatively by the ability to insert modules effectively. PATIENT POSITIONING The patient is positioned prone on a lumbar frame that promotes suitable exposure and restores sagittal alignment. Use of c-arm intraoperative radiographic equipment is recommended to assure operative site selection, confirm the precise position of the InterFuse T device implant and minimize surgical exposure. VTI VTI-SPINE.COM 7/20

8 STEP TWO DISC REMOVAL AND ENDPLATE SHAPING IDENTIFY LANDMARKS Create a posterior lateral incision and identify anatomical landmarks If a pedicle screw system is used, place screws prior to implantation. They may be used for temporary disc distraction during implant insertion If a facet screw system is used, lateral exposure only to the facets may be used Percutaneous facet screws may be placed on the contralateral side only after distraction has been attained Fig. 1 DISTRACTION Parallel distraction of the disc provides easier insertion of modules and ensures sufficient device height Distraction can be applied between pedicle screw heads using a lateral distractor. Hold distraction with pedicle rods if distractor removal is desired Alternatively, place a spreader at the lamina or base of the spinous process (Fig. 2) Distraction may be maintained with screws and rods following use of the spreader Fig. 2 VTI VTI-SPINE.COM 8/20

9 ACCESS CHANNEL Create an access channel to the annulus by performing a unilateral facetectomy (Fig. 3) Fig ANNULOTOMY AND CORTICAL RIM Continue the access channel through the posterior annulus and cortical rim (Fig. 4) Create a rectangular annulotomy approximately to the vertical using a #11 blade (Fig. 5a) Shape the corners of the cortical rim to ensure the access is rectangular (highlighted in green, Fig. 5b) If a paddle shaver is used to create the access channel, Kerrison rongeurs are useful for squaring the corners Fig. 4 Use a Device Sizer to determine whether the access channel is sufficient. Fig. 5b TIPS FOR SUCCESS Fig. 5a Do not extend the access channel into the central endplates. Doing so will create a ridge that can impede lateral movement of the modules into the disc space VTI VTI-SPINE.COM 9/20

10 NUCLEUS REMOVAL Completely remove the disc nucleus and endplate cartilage Pay special attention to removal of disc material contralateral and ipsilateral to the annulus access. In addition, remove any posterior osteophytes medial to the annulotomy Ensure that the anterior and lateral walls of the annulus are preserved during cleanout Use the Nucleus Probe (Fig. 6) to check for proper cleanout of disc material ipsilateral and contralateral to the annulus access WARNING: Excessive removal of subchondral bone may weaken the vertebral endplate and result in implant subsidence and loss of segmental stability. TIPS FOR SUCCESS The most important aspect of a successful surgical outcome is performing a complete discectomy Disc material remaining within the cavity will impede module insertion and limit the ability to maximize the device footprint. Irrigate and aspirate the disc space to ensure any remaining soft tissue is removed Fig. 6 Care should be taken not to create a bony ledge in the central portion of the disc medial to the access channel. This will impair movement of subsequent modules across the midline VTI VTI-SPINE.COM 10/20

11 STEP THREE DEVICE SIZING AND PREPARATION SIZING Use Device Sizers (Fig. 7) to determine final implant size Final height is determined when the Device Sizer fits securely but does not require use of the slap hammer for removal The curved face of the Sizer must be contacting the endplates (A list of available device sizes can be found on pg. 18) Fig. 7 BONE GRAFT MATERIAL Place bone graft material in the bone growth window of each module (Fig. 8) Bone graft volume (in cc) for each device is located in the Bone Graft Volume (cc) table below Fig. 8 BONE GRAFT VOLUME (cc) SIZE VOLUME TIPS FOR SUCCESS Ensure that no bone graft material is in the implant s rail or lock (see arrows in Fig. 8). Material in these areas can interfere with engagement and locking of the modules. 7 x 20 mm x 20 mm x 20 mm x 20 mm x 20 mm x 20 mm x 20 mm 2.0 VTI VTI-SPINE.COM 11/20

12 STEP FOUR IMPLANTATION Fig. 9e Fig. 9a Fig. 9b TIPS FOR SUCCESS Fig. 9c Fig. 9d The first A module should be able to enter the disc space smoothly and without resistance Resistance to placement of the A module may indicate additional cleanout is required Intraoperative c-arm imaging may be used throughout the procedure to visualize proper module placement and construct positioning A MODULE INSERTION Use the Insertion Guard to insert the A module through the annulotomy (Figures 9a and 9b). Take special care to ensure that the curved portion is oriented medially and the serrated edges are contacting the vertebral endplates The InterFuse T device can be successfully inserted at an angle of 15º to 35º (Fig 10). Use the Positioning Lever to move the module medially (Fig 9c). Place the distal end of the A module s tail midway between the markings on the Positioing Lever to ensure the ramp lock is not damaged (Fig 9e). The tail of the A module should be protruding from the disc space. Fig. 10 Remove the Insertion Guard (Fig 9d). VTI VTI-SPINE.COM 12/20

13 B MODULE INSERTION Load the B module onto the insertion guard and insert the tail of the A module in to the anterior portion of the slot of the B Module. Carefully slide the B module over the tail of the A module until it is completely within the disc space (Figures 11a through 11c). THE MODULES MUST BE PARALLEL TO ONE ANOTHER PRIOR TO THE B MODULE ENGAGING THE A MODULE TO PREVENT PRE-MATURE REMOVAL OF THE TAIL. A mallet may be used to help engage the B module. Hold the lever of the insertion guard tight against the body of the insertion guard when using a mallet to ensure the insertion guard does not come loose. Do not use a mallet until the tail of the previous segment is at least to the hammer-safe line (denoted by the green arrow in Fig 12b). Fig. 11a Fig. 11b Fig. 11c Hammer Safe Line Engage the A and B Modules by simultaneously pulling up on the A Module s Tail while pushing down on the B Module s Insertion Guard. The B module is fully engaged when both of the tails are flush with one another. Fig. 12b VTI VTI-SPINE.COM 13/20

14 TAIL REMOVAL Ensure that the tails are parallel to and flush with one another. In order to remove the Tail of each module slide the Tail Removal Tool over the tail and down to the disc space. For A modules, the A tail will be flush with the top of the Tail Removal Tool (green arrow, Fig 13). For B modules, the B tail will be approximatley 4mm below the top of the Tail Removal Tool (green arrow, Fig 14). Fig. 13 The Tail Removal Tool must be flush with the implant (Fig 15) so as not to leave any excess material behind that could disturb the healing process. Cut the tail by rotating the Tail Removal Tool 360 degrees. Once the tail has been fully severed, slide both the Tail Removal Tool and the tail out of the disc space. Fig. 14 TIPS FOR SUCCESS Use of a nerve root retractor is strongly recommended during tail removal. Do not remove the tail of the B module until the C module has been inserted. Fig. 15 Fig. 16 VTI VTI-SPINE.COM 14/20

15 C MODULE INSERTION Prior to C module insertion, use the Positioning Lever to move the engaged A and B module construct medially. Remove the Insertion Guard from the B module. Fully thread the C module onto the threaded inserter. Insert the B module tail into the C module slot. Carefully slide the C module along the tail of the B module until it is completely within the disc space (Fig 16a) A mallet may be used to insert the C module. Do not mallet until the B module is past the hammer safe line (Fig 16a). Once you have slid the C module into the disc space, engage the B and C modules by simultaneously pulling up on the B module's Tail while pushing down on the C module's Threaded Inserter. (OPTIONAL) With a Tail Traction Tool attached to the B module tail, engage the modules by simultaneously pulling up on the Tail Traction Tool and pushing down on the C module When the C module is fully engaged the remaining B tail should be just below the top ring on the Threaded Inserter (the green arrow in Fig. 16a points to the top ring) Confirm that the C module is fully engaged by gently pulling back on the Threaded Inserter S T Top of Black Line Module alignment should also be verified by reviewing the marker bead location using intraoperative C-arm (see pg. 3 for x-ray marker locations) Hammer Safe Line If needed, a 3D bead placement model is available to help correlate the marker bead locations to the device After insertion remove the final B tail following the procedure outlined in the Tail Removal section (pg. 14) Fig. 16a Fig. 16b VTI VTI-SPINE.COM 15/20

16 MODULE DISENGAGEMENT If at any point one module needs to be removed, use the Module Disengagement Tool. Prior to use of the Module Disengagement Tool, make sure a nerve root retractor is in place to protect the exiting nerve rootlet. To use the Module Disengagement Tool, screw the Threaded Inserter into the module that is to be removed. If the threads in the module are damaged use the Extraction Tool in place of the threaded inserter. Slide the Module Disengagement Tool down the length of the tail of the previous module shown in Figure 17a. Disengage the module by pressing down on the handle of the Module Disengagement Tool (Figure 17b). Fig. 17a Fig. 17b VTI VTI-SPINE.COM 16/20

17 CLOSURE A routine wound closure is performed following completion of the InterFuse T device implantation Prior to closure, attention to the posterior fixation should include adjusting down the rod separation on the pedicle screws to attain desired sagittal alignment POSTOPERATIVE CARE Routine monitoring of the vital signs, and of the hemodynamic and neurologic status of the patient Pain medication NG tubes and/or Foley catheters, if used, are discontinued within hour Diet is restricted to small amounts of liquids until return of bowel function is completed The patient is encouraged to ambulate as soon as possible. The individual surgeon determines activity level for the patient External bracing is to be used per each surgeon's discretion VTI VTI-SPINE.COM 17/20

18 PRODUCT LISTING INTERFUSE T IMPLANT SYSTEM Catalog Number Implant (Height x A-P Length) 07mm x 20mm Parallel 08mm x 20mm Parallel 09mm x 20mm Parallel 10mm x 20mm Parallel 11mm x 20mm Parallel 12mm x 20mm Parallel 14mm x 20mm Parallel 07mm x 20mm 10 Angle 08mm x 20mm 10 Angle 09mm x 20mm 10 Angle 10mm x 20mm 10 Angle 11mm x 20mm 10 Angle 12mm x 20mm 10 Angle 14mm x 20mm 10 Angle INTERFUSE INSTRUMENT SET Catalog Number Description Device Sizer, 7mm x 20mm Device Sizer, 8mm x 20mm Device Sizer, 9mm x 20mm Device Sizer, 10mm x 20mm Device Sizer, 11mm x 20mm Device Sizer, 12mm x 20mm Device Sizer, 14mm x 20mm Threaded Inserter Positioning Lever Concave Slap Hammer Nucleus Probe Instrument Tray Tail Removal Tool Insertion Guard Tail Traction Tool Module Disengagement Tool 9151 Extraction Tool Nerve Root Retractor Bayoneted Nerve Root Retractor VTI VTI-SPINE.COM 18/20

19 PRODUCT LISTING CONT COMPREHENSIVE DISC PREP INSTRUMENT SET Catalog Number Description Bayoneted Angled Forward Gouge MIS Angled Backward Gouge MIS Left Bent Oval Curette MIS Right Bent Oval Curette MIS Right Bent Ring Curette Angled Forward Gouge Angled Backward Gouge Left Bent Oval Curette Right Bent Oval Curette Bent Hooked Gouge Right Bent Ring Curette Bayonetted Up Bent Triangle Curette Up Bent Triangle Curette Straight Endplate Rasp Bent Endplate Rasp Comprehensive Disc Prep Tray or Straight Pituitary Rongeur - 3mm or Straight Pituitary Rongeur - 4mm or or Up-Biting Pituitary Rongeur - 3mm or Up-Biting Pituitary Rongeur - 4mm 15x25 Curved Pituitary Rongeur - 3mm or 15x25 Curved Pituitary Rongeur - 4mm 40 degree Kerrison Rongeur - 4mm degree Kerrison Rongeur - 4mm SHAVER / DISTRACTOR INSTRUMENT SET Catalog Number Description Paddle Distractor, 07mm Paddle Distractor, 08mm Paddle Distractor, 09mm Paddle Distractor, 10mm Paddle Distractor, 11mm Paddle Distractor, 12mm Paddle Distractor, 13mm Paddle Distractor, 14mm Paddle Distractor, 15mm T Handle Paddle Shaver Instrument Tray Shaver, Size 6 Shaver, Size Shaver, Size Shaver, Size Shaver, Size 10 Shaver, Size 11 Shaver, Size Shaver, Size Shaver, Size 14 VTI VTI-SPINE.COM 19/20

20 Please refer to the InterFuse Interbody Fusion Device package insert for further information on: CONTRAINDICATIONS WARNINGS & PRECAUTIONS INSTRUMENT CLEANING & STERILIZATION CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. The InterFuse T Interbody Fusion Device Surgical Technique is presented to demonstrate the surgical technique utilized by a contributing panel of surgeons 1. Vertebral Technologies, Inc., as the manufacturer of this device, does not practice medicine and does not recommend this product or any specific surgical technique for use on any specific patient. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each specific patient. For further information, contact: Vertebral Technologies, Inc Industrial Park Blvd. Minneapolis, MN (952) Visit us online at: vti-spine.com InterFuse T Surgical Technique DCO MS 4050 Rev. P 1 Names of contributing surgeons available upon request. NOTES VTI VTI-SPINE.COM 20/20